To compare the effectiveness (efficacy, safety & tolerability) of a Single Tablet Regimen of efavirenz/emtricitabine/tenofovir DF to subjects continuing on unmodified HAART as measured by the proportion of patients who maintain viral load (HIV-1 RNA) <200 copies/mL at Week 48.

Patients must be on their first HAART or have documented viral suppression on a PI-based regimen at the time of any prior change in therapy.

HAART must consist of either:

A PI (with or without ritonavir) + at least 2 NRTIs or

An NNRTI + at least 2 NRTIs.

Negative serum pregnancy test.

Exclusion Criteria:

Patients who have taken any NNRTI prior to their current therapy.

Patients who have taken a NRTI-only therapy for greater than 7 days prior to their current therapy.

Patients who are currently taking EFV+FTC+TDF.

Patients who have a creatinine clearance of <60 mL/min by Cockcroft-Gault estimation.

Patients who have experienced virologic failure with any previous ARV therapy.

Patients who have documented resistance to any of the study agents at any time in the past.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365612